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Trial record 16 of 444 for:    Methylphenidate

Methylphenidate Effect on Humphrey Visual Fields

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ClinicalTrials.gov Identifier: NCT02162381
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Bialer, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date April 11, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date April 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
improvement rate of a repeat visual field result [ Time Frame: immediate ]
the percentage of subjects whose second (repeat) visual field has improved compared to the first visual field - as interpreted by independent blinded ophthalmologists
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02162381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Humphrey visual field Mean Deviation (MD) [ Time Frame: immediate ]
    the MD of the Humphrey visual field in the study and control groups will be compared
  • Humphrey visual field severity score [ Time Frame: immediate ]
    based on the Humphrey visual field gray scale each visual field will be given a score between 1 and 4. 1 = normal 2=enlargement of the blind spot 3=either a nasal or temporal visual field 4= diffuse visual field loss
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylphenidate Effect on Humphrey Visual Fields
Official Title  ICMJE Methylphenidate Effect on Performing Humphrey Visual Fields
Brief Summary Study will include adults with abnormal visual fields. Half of them will be given either methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as controls. All Subjects will also have a complete eye examination, a short questionnaire and a questionnaire to screen for attention deficit disorder. The investigators will compare the visual field results between the 2 tests.
Detailed Description

Healthy adults with abnormal visual fields will be offered to participate Subjects will have a complete ophthalmic examination including dilated fundus examination.

Subjects with clear explanation for a visual field defect (e.g. optic neuropathy or retinal disorder) will be excluded from the study the subjects will be randomly assigned to the study group and control group using a 1:1 allocation.

Subjects in the study group will be provided with a single tablet of methylphenidate 10 mg to be taken orally 2 hours before repeating their visual field test.

The control group will not receive any placebo Both groups will repeat their visual fields. Both groups will fill out a short questionnaire to evaluate their experience in the second visual field test.

The study group will also fill out a screening questionnaire to rule out previously undiagnosed attention deficit disorder.

Two experienced ophthalmologists will separately interpret the visual fields results and compare the first and second visual fields of each subject, while being blinded to which group he was in.

Subjects will be provided with their test results and the ophthalmologist interpretation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Visual Field Tests
Intervention  ICMJE
  • Drug: methylphenidate
    a single dose of methylphenidate 10 mg to be taken orally in the morning
    Other Name: Ritalin
  • Other: guidance
    subjects will be given an explanation and advice about how to perform well in visual field testing
Study Arms  ICMJE
  • Experimental: methylphenidate provided
    the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test
    Interventions:
    • Drug: methylphenidate
    • Other: guidance
  • Active Comparator: control
    control group will not be given any placebo and will perform a repeat visual field testing without any prior preparation
    Intervention: Other: guidance
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
30
Actual Study Completion Date  ICMJE April 10, 2018
Actual Primary Completion Date April 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • abnormal visual fields
  • must be able to swallow pills

Exclusion Criteria:

  • psychiatric disorder
  • dementia
  • ocular disorder which is known to cause abnormal visual fields
  • prescription of psychoactive medications
  • visual acuity lower than 20/100
  • cardiac arrhythmia
  • hypersensitivity to methylphenidate
  • prescription of warfarin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162381
Other Study ID Numbers  ICMJE 0105-14-RMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bialer, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omer Y Bialer, M.D. Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP